FDA.reportPublic FDA data

NA

Primary DI
10885862058065
Brand
NA
Company
Exactech, Inc.
Model
213-03-05
Catalog number
213-03-05
Device description
INTRA-MEDULLARY ALIGNMENT, GUIDE BUSHING, LPI BETA, 5°, 8mm
Published
2022-08-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K032606000
K033883000
K093360000
K111400000
K121307000
K123687000
K140302000
K935773000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032606000OPTETRAK TOTAL KNEE SYSTEM ASYMMETRIC FEMORAL COMPONENTS SIZE 6 PSOTERIOR-STABILIZING, CEMENTED FEMORAL COMPONENTSExactech, Inc.2003-09-23JWH
K033883000OPTETRAK TOTAL KNEE SYSTEM, HI-FLEX ASYMMETRIC POSTERIOR-STABILIZED CEMENTED FEMORAL COMPONENTS, HI-FLEX POSTERIOR-STABIExactech, Inc.2004-02-13JWH
K093360000OPTETRAK LOGIC TOTAL KNEE SYSTEM TRAPEZOIDAL TIBIAL TRAY, SIZES 2.5F/1.5T-3.5F/4.5TExactech, Inc.2010-01-11JWH
K111400000OPTETRAK LOGIC CR TIBIAL INSERT, OPTETRAK LOGIC CR FEMORAL COMPONENTExactech, Inc.2011-07-28JWH
K121307000OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 0 OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 6 OPTETRAK LOGIC CR FEMORAL COMPONENT, SIZExactech, Inc.2012-05-31JWH
K123687000OPTETRAK LOGIC POROUS FEMORAL COMPONENTExactech, Inc.2013-03-20JWH
K140302000OPTETRAK LOGIC POROUS FEMORAL COMPONENTSExactech, Inc.2014-07-30MBH
K935773000EXACTECH POROUS COATED POSTERIOR STABILIZED FEMORAL COMPONENTExactech, Inc.1994-12-09JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885862058065PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088586205806510885862058065

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle5degree
Lumen/Inner Diameter8Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
157565946
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885862094780OpteCure650-00-01650-00-012016-07-17
10885862094797OpteCure650-00-02650-00-022016-07-17
10885862094803OpteCure650-00-05650-00-052016-06-17
10885862094810OpteCure650-00-10650-00-102016-07-17
10885862094827Optecure650-00-20650-00-202016-09-19
10885862094841OpteCure+CCC652-00-01652-00-012016-07-17
10885862094858OpteCure+CCC652-00-02652-00-022016-07-17
10885862094865OpteCure+CCC652-00-05652-00-052016-07-17
10885862094872OpteCure+CCC652-00-10652-00-102016-07-17
10885862094889OpteCure+CCC652-00-20652-00-202016-07-17
10885862095039Ossigen660-00-20660-00-202016-07-17
10885862252593Entice +CCC692-00-01692-00-012016-07-17
10885862252609Entice +CCC692-00-02692-00-022016-07-17
10885862252616Entice +CCC692-00-05692-00-052016-07-17
10885862252623Entice +CCC692-00-10692-00-102016-07-17
10885862252630Entice +CCC692-00-20692-00-202016-07-17
10885862252845Entice690-00-01690-00-012016-07-17
10885862252852Entice690-00-02690-00-022016-07-17
10885862252869Entice690-00-05690-00-052016-07-17
10885862252876Entice690-00-10690-00-102016-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05056139247712Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247729Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247736Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247743Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247767Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247774Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247781Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247798Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247897Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247903Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247910Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247927Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247934Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247996Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139248009Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139248016Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139248023Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139248030Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139248108Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139248115Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139248122Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139248139Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139248191Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139248207Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139248214Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139248221Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139248238Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139248290Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139248306Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139248313Unity Total Knee SystemCORIN LTDJWH2026-10-19